Document Specialist – Regulatory Publishing (India)
Location: India | Experience: 3+ years | Work Mode: Remote/On-site (unspecified)
Company: ProPharma Group | Job Type: Full-time
Job Summary
ProPharma Group is hiring an experienced Document Specialist to support the regulatory publishing of critical submission documents for the pharmaceutical, biotech, and medical device industries. This role involves advanced formatting, PDF processing, and document compilation for eCTD submissions, ensuring accuracy, quality, and compliance with global regulatory standards like ICH, EU MDR, and FDA.
If you have expertise in Microsoft Word, Adobe Acrobat, and eCTD tools, and are passionate about helping life science companies bring therapies to market, this is the ideal opportunity.
Key Responsibilities
Format, review, and compile regulatory documents (Word and PDF) for submissions including IND, CTA, NDA, BLA, and MAA.
Convert documents to PDF format with appropriate bookmarks, hyperlinks, and metadata for eCTD compliance.
Ensure documents meet all client and regulatory formatting standards and submission specifications.
Perform pre- and post-publishing quality checks.
Collaborate directly with clients and internal teams during submission preparation.
Manage multiple publishing projects and meet established timelines.
Participate in internal process improvement initiatives.
Maintain up-to-date knowledge of regulatory guidelines (e.g., ICH E3/E6/M4, EU MDR/IVDR).
Perform peer reviews and escalate issues when needed.
Required Skills & Qualifications
Bachelor’s degree (life sciences or related field preferred).
Minimum 3 years of experience in document publishing or formatting.
Proficiency in Microsoft Word (advanced formatting) and Adobe Acrobat.
Familiarity with eCTD publishing tools (e.g., ISI Toolbox, Core Dossier).
Experience with pharmaceutical/biotech submission types (INDs, CTAs, NDAs, BLAs, MAAs).
Strong problem-solving, project management, and communication skills.
English language fluency.
Ability to work independently and handle multiple projects.
Perks & Benefits
Work with a global leader in regulatory consulting and life sciences services.
Dynamic and inclusive workplace fostering innovation.
Opportunity to support scientific breakthroughs and product approvals.
Flexible, collaborative, and growth-focused environment.
Participation in high-impact pharmaceutical and medical device submissions.
Company Description
ProPharma Group is a global provider of regulatory sciences, pharmacovigilance, medical information, and clinical research solutions for pharmaceutical, biotech, and medical device companies. With 20+ years of expertise, we partner across the full product lifecycle to help clients accelerate innovation and ensure compliance.
Work Mode
Not explicitly stated – likely Remote or Hybrid (based in India).
Call-to-Action
Are you ready to contribute to global drug approvals and regulatory excellence? Apply now to join ProPharma Group as a Document Specialist and play a pivotal role in the life sciences industry's most mission-critical submissions.
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